TitlePilot Study of Biomarkers of Response to Immune Checkpoint Blockade in Metastatic Melanoma

ObjectiveThe purpose of this research study is to determine if testing on blood and tissue samples, and analysis of PET/CT scans, can help researchers determine which patients are more or less likely to respond to treatment with anti-PD1 immunotherapy. Current drugs in this category include pembrolizumab and nivolumab. In the future, this information may help physicians better tailor treatment plans for their patients.

TreatmentParticipating in this research study does not change your cancer treatment in any way.

DescriptionPrior to starting treatment, you will have a prior and current medication review, review of symptoms and adverse events, imaging and collection of research blood and tissue samples. At week 4-6 you will have a prior and current medication review, review of symptoms and adverse events and collection of research blood and tissue samples. At week 10-12 you will have a prior and current medication review, review of symptoms and adverse events, imaging, and collection of research blood and tissue samples. At week 16-18 you will have a collection of research blood and tissue samples, if still receiving treatment. These visits will take approximately 1-2 hours. This time does not include the time for imaging scans.

Key Eligibility

Participants must have a metastatic melanoma diagnosis (stage IV) for which treatment with nivolumab or pembrolizumab, either alone or in combination with other therapies, is planned

Participants must have at least 2 subcutaneous or lymph node melanoma metastases that are 2 cm in greatest diameter and are amenable to being biopsied in clinic without requiring image-guidance

Participants must be >18 years of age or older

Women of childbearing potential must be willing to use effective contraception as discussed with their oncologist while participating in this study

Patients who are not able to receive treatment with either nivolumab or pembrolizumab are ineligible

Women of child-bearing potential must have a negative serum or urine pregnancy test within 7 days of the first study FDG and FLT PET/CT and must not be breast feeding for the duration of study participation